Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis

NCT01115244 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 100273
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the efficacy of dapsone gel, 5% in the treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion of patients achieving success based on mean % reduction from baseline in total lesion counts at week six. Success for lesion reduction will be defined as statistically greater mean percent reductions at week six in the dapsone gel-treated extremity compared with the control extremity of each patient.

Conditions

Dermatitis Herpetiformis

Keywords

Dermatitis herpetiformis; Dapsone

Outcome Measures

Primary Outcomes (1)

• Number and Size of All Lesions on the Treated and Untreated Elbows or Knees of Patients With Dermatitis Herpetiformis Who Have One Extremity Treated With Dapsone Gel, 5%

  The primary objective is to evaluate the efficacy of dapsone gel, 5% in the treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion of patients achieving success based on mean % reduction from baseline in total lesion counts at week six. Digital photographs of each elbow or each knee (treatment and control) will be taken. The number and size of lesions will be recorded for the treatment and control elbow or knee. This process will be repeated at each follow up visit.

  6 weeks of treatment

Secondary Outcomes (2)

• Number of Papules, Plaques and Vesicles on Treated and Untreated Elbows or Knees of Patients Who Have One Extremity Treated With Dapsone Gel, 5%

  6 weeks of treatment

• Evaluation of Clinical Photographs and Scoring of Photographs Based on a Modified Global Acne Assessment Score

  6 weeks of treatment

Study Arms (2)

Dapsone gel, 5%

EXPERIMENTAL

ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.

Drug: Dapsone gel, 5%

Not treated

NO INTERVENTION

One arm of the patient will be left untreated.

Interventions

Dapsone gel, 5% DRUG

ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.

Also known as: ACZONE™ (dapsone) Gel, 5%

Dapsone gel, 5%

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 12 years or older
• Clinical diagnosis of dermatitis herpetiformis, as previously diagnosed by the patient's primary dermatologist or diagnosed by agreement of the two investigators
• Active disease at time of enrollment, defined as at least five inflammatory lesions (to include papules, plaques and vesicles) on the bilateral elbows or bilateral knees

You may not qualify if:

• Patients taking oral dapsone or those who have taken oral dapsone within four weeks prior to enrollment
• Patients using any other topical treatment for dermatitis herpetiformis at time of enrollment or within the four weeks prior to enrollment
• Patients with known allergy or hypersensitivity to dapsone, sulfa drugs or excipients of the dapsone gel product
• Women will be excluded if pregnant or nursing
• Women of childbearing potential must be practicing an effective method of birth control as determined by the enrolling physician. If oral contraceptives are the method of choice, then the patient must have been on a stable dose for a minimum of 3 months. (This is the same guideline used for women of childbearing potential in previous studies of acne patients.)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University - One Hundred Oaks

Nashville, Tennessee, 37204, United States

Location

MeSH Terms

Conditions

Dermatitis Herpetiformis

Interventions

Dapsone; Gels

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Mary Beth Cole
• Organization: Vanderbilt University Medical Center

(615) 322-6485

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 4, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 14, 2017
• Results First Posted: December 14, 2017

Record last verified: 2017-11

Locations

US (1)